MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jul 13, 2026
Report 0001526350-2026-00833 · MDR key 25804286
Device
Product problems
- Gas/Air Leak
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEVICE HAD A GAS LEAK. PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(b)(4).G2: FOREIGN - EVENT OCCURRED IN CANADA.CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.